Infectious diseases which once decimated entire populations are now largely controlled by modern drugs and sanitation methods. One virus, however, has remained elusive to medical science, and is infecting the human population in epidemic proportions. The human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS), once generally regarded as a malady of homosexuals and intravenous drug abusers, has become a threat to all strata of society. In most instances, this virus leads to AIDS, and eventually death. Prior to the present invention, there was no known cure, nor were there any effective treatments for controlling the virus without causing unwanted side effects.
Some scientists believe that HIV may have been introduced into the human population through use of polio vaccines made from the tissue of infectious African green monkeys, many of which have been discovered to be infected with a retrovirus related to HIV. The rapid spread of this disease, however, is generally believed to be transmitted through infected blood and blood products, and through sexual contact. Drug abusers sharing used intravenous needles, persons receiving blood transfusions, and homosexuals and heterosexuals engaging in "unsafe" sexual contact are particularly vulnerable.
Intense efforts are being made to reduce the infectious risk of human blood products, and to control the spread of the virus among the human population.
Most efforts have been directed toward the development of drugs for controlling or killing the virus, but unlike most viruses, HIV becomes part of the genetic code of the cell. In order to kill the virus, it is necessary to destroy the cell. Moreover, the virus changes from individual to individual, and even within one person it can mutate in a matter of hours. This makes it virtually impossible to develop a drug specific to the virus, although some drugs, such as AZT, have shown promising results in neutralizing the virus. Unfortunately, AZT also produces serious side effects in many people because of its toxicity, and its use is therefore limited.
Because of these difficulties, other treatments have been tried or proposed, including thermal inactivation of viruses in blood derivatives, gamma-irradiation, porous membrane filtration, and solvent/detergent mixtures. However, these methods generally produce deleterious side effects and have achieved only limited success.
The prevailing view has been that by carefully screening blood and blood products to detect and eliminate contaminated materials, and by preventing the sharing of used needles among intravenous drug users, and by practising safe sex, the risk of transmission of the disease can be minimized. All of these methods are effective and do help reduce the rate of spread of the disease, but they do not offer a treatment or cure for the disease once a person becomes infected.
Moreover, lax and ineffectual screening of blood donors, and unreliable methods for detecting contaminated blood supplies, result in numerous instances of infected blood being made available for use in patients needing blood transfusions. Further, intravenous drug abusers generally do not pay heed to the dangers of sharing a needle; and passion, rather than prudence, usually controls sexual behavior.
Recent studies also indicate that the virus may be transmitted in ways other than previously believed. For instance, some scientists now believe that the HIV may be transmitted through mucous membranes, or even the skin. Dendritic cells move through the skin and mucous membranes searching for foreign proteins like bacteria and viruses. They pick up these foreign proteins and carry them to the lymph nodes, where T4 cells are stimulated to multiply and migrate into the blood to destroy the foreign invader. T4 cells are primed to die once they are infected, and over time the reduction in the number of T4 cells available to fight infection leads to collapse of the immune system.
Regardless of how the disease is transmitted, people are becoming infected at an alarming rate and an effective treatment is needed.
Ozone, the triatomic allotrope of oxygen, is a potent oxidant that has been shown to possess broad spectrum anti-microbial activity. It has been widely used in the treatment of sewage and in the purification of water, and was used medically in the treatment of wounds at least as early as World War I.
Advancements made by scientists in recent years using ozone to inactivate viruses, bacteria, fungi and protozoa have been well documented. It has reportedly been successfully used in several countries, most notably West Germany, in the treatment of AIDS, and specifically to inactivate HIV. In these treatments, ozone is generated from medically pure oxygen by electrical corona arc discharge. Blood from the patient being treated is then exposed to the ozone for a predetermined period of time, and at predetermined ozone concentrations to inactivate the virus.
In these prior art systems, the patient is treated with ozone by rectal insufflation, or by minor or major autohemotherapy. Much of the existing technology relies upon bubbling techniques to contact the blood or blood components with ozone/oxygen mixtures.
These methods offer inferior surface contact between the gas and blood, with little or no absorption controllability. Blood cells are also mechanically damaged by the bubbling techniques or porous membrane filters used in such methods, and it is difficult to control the concentrations of ozone necessary to inactivate the virus without adversely affecting normal biological and metabolic functions of the remaining blood components.
Further, treatment times are excessively long in prior art methods, taking up to eleven months for a full treatment protocol. This long treatment time makes conventional methods impractical for global treatment of the HIV epidemic. Moreover, excessively long treatment times cause discomfort and stress to the patient.
In addition, ozone is produced in accordance with prior art methods by using either low frequency (typically 50-60 Hz) or other, higher frequency generators. These methods of generation induce corresponding resonant frequencies in the ozone molecules, which, when exposed to the blood, expose the DNA to unnatural frequencies. Some research indicates that exposure to such frequencies can produce abnormal DNA activity and cell growth (cancer).
Consequently, even though ozone has shown promise in the inactivation of HIV, the shortcomings of prior art apparatus and methods have limited its use and hindered its acceptance as a viable medical tool.
There is thus need for an apparatus and method for using ozone in the treatment of blood contaminated with HIV, which enables accurate control over the process and in which treatment time is very short. Preferably, the apparatus and method should inactivate HIV but not adversely affect normal biological or metabolic activity in the blood, and should not involve the use of filters, bubblers, and the like, which can cause mechanical damage and trauma to the blood cells.